BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists, and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.

MSAT Drug Product Scientist/Process Engineer

The Team

MSAT Frontline are responsible for being the primary interface between Manufacturing operations and the MSAT team, supporting a given product and/or process prior to, during and post-campaign. MSAT Frontlines primary role is to ensure that the manufacturing process performs as developed and validated while ensuring continuous process improvement through the application of scientific and engineering expertise. The role involves high levels of cross functional collaboration in areas such as technology transfer, process scale up, process performance monitoring and optimization, continuous improvement, and impact analysis. The role will combine scientific, engineering, and operational leadership as well asutilising Root Cause Analysis, Statistical Analysis and Experimental Design. The Scientist/Engineer will also be able to demonstrate impactful communication of complex scientific and engineering concepts to non-technical audiences.Furthermore, this position requires a high degree of familiarity with cGMP and Quality Systems involved with both clinical and commercial manufacturing processes.

Role Summary

As part of establishing the sterile filling operation at the Shanbally facility, this role will play an important part in the start-up of the facility, by interfacing and developing a close working relationship between the manufacturing sciences lab team and DrugProduct manufacturing.  The role will contribute to process understanding, manufacturing best practices for filling and isolator technology with focus on the continuous improvement, personal development, and demonstration of production techniques that will result in agile and compliant manufacture of Drug Product material for both clinical and commercial filling of the BioMarin biologics product portfolio.

Duties

The MSAT DP Scientist/Engineer will actively interface and collaborate with manufacturing operations, external partners and the BioMarin global drug product network. The role will work collaboratively providing SME input to technical delivery of NPI and TT projects and on best practices across all areas of the drug product manufacturing process. The scientist/engineer will provide SME support fromstartup activities, will provideinvestigational supportof deviations once PPQ is complete, lead and/or contribute to MSAT lab studies and investigations.

Main areas of responsibility:

• Act as Subject Matter Expert (SME) for fill finish operations and processes 
• Support NPIs and Tech transfers by working collaboratively both internally and with external CMOs
• Provide technical input to technology transfer related documents (e.g.,clinical, and commercial protocols, batch records, PV documents, equipment user requirements)
• Support and may lead investigations utilizing the MSAT lab capability and external labs as required. This may require ownership of deviations and other documentation such as SOPs, reports.
• Contribute to and lead, when appropriate, lab studies related to DP filling such as mixing studies, cleaning studies, filter integrity testing, extractable & leachable studies

• Help establish and expand manufacturing sciences capability to support DP manufacturing operations.
• As the technical SME provide technical expertise and discussion during GMP audits from regulatory authorities
• Provide SME input to aseptic filling and visual inspection, including technical assistance and deviation investigation.
• Identify and progress continuous improvements utilizing new processes, equipment, or technology for the drug product facility.
• Work closely with the other GMSAT Team members, be engaged in the planning of experiments resulting from campaign learnings to increase process robustness and reduce Cost of Goods Manufactured (COGM)

• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
• Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools
• Develop, define scope, and support the implementation of technical solutions under the guidance of site change control systems
• Accountable for data integrity and scientific conclusions from assigned scientific projects

Experience / Skills

• Bachelor’s degree in biochemistry, biology, biochemical engineering, or related field with 6+ years relevant experience; Master’s degree with 4+ years; PhD with 2+ years
• Other continuing education initiatives highly desirable (e.g., Six Sigma, Lean Manufacturing, industry specific coursework)
• Experienced in cGMP and large-scale manufacturing equipment and practices and with the transfer of technology to cGMP operations.
• Detailed knowledge and previous experience in sterile fill finish operations and/or DP visual inspection and defect library creation and maintenance is highly desirable.

• Understanding of basic statistical data analysis and a willingness to explore advanced statistical modelling tools.
• Demonstrated effective communication, oral and written, in a multi-disciplinary, project-driven work environment.
• Demonstrated skill in leading project teams tasked with resolving complex production related issues.
• A strong understanding of laboratory analyticaltechniquesishighly desirable, with emphasis on bio-analytical and technical knowledge relating to particulate (visible and sub-visible) identification and characterization.
• Demonstrated ability of excellent communication, demonstrated problem-solving skills and strong ability to interact across cross-functional teams.

• Experience and proven track record to successfully influence team performance.
• Expertise in planning and designing experimental work and in data analysis and interpretation
• Aseptic drug product experience preferable.
• Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.